diabetes update

1

Diabetes Update 2013

Dr. Erin Koepf, PharmD, BCACPAssistant Professor, Ambulatory Care

University of New England College of PharmacyMaine Pharmacists Association, September 7, 2013

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Objectives:

• Based on the American Diabetes Association Standards of

Medical Care in Diabetes – 2013:

• Identify the classification, risk factors, diagnosis, and

screening criteria for diabetes

• Explain pharmacologic and non-pharmacologic treatments

options for patients with diabetes or pre-diabetes

• Describe measures that can be taken to prevent diabetes

progression and complications including immunization

recommendations

3

Objectives:

• Identify the class, mechanism of action, dosing, and administration

of new and common diabetes medications

• Discuss with patients and other health care practitioners diabetes

treatment options, monitoring, and the goals for therapy

• Compare and contrast medication therapies available for the

treatment of diabetes and select appropriate options for a given

patient

• Develop a comprehensive care plan for a given patient with

diabetes which included pharmacologic and non-pharmacologic

measures, monitoring, and preventative measures

4

“What is Diabetes?” Warm-up

• Spend 60 seconds thinking about and writing down a

description of Diabetes

• Spend the next 2 minutes sharing your description

with someone next to you

• Write down some of the concepts you come up with

5

“What is Diabetes?” Warm-up

•Endocrine condition that increases risks of

Cardiovascular events v.

•Cardiovascular disease with abnormal processing and

distribution of glucose

•Others?

6

Review: Diabetes Pathogenesis

• Insulin deficiency

• Quantitative: decreased in production by the β-cells of the

pancreas

• Qualitative: insulin resistance especially muscle, liver,

adipose, myocardial

• Improvements in insulin function

• Weight loss to decrease insulin resistance

• Can in turn improve β-cell function

7

Review: Diabetes Pathogenesis

• Excess secretion of glucagon by α-cells of pancreas

• Glucose overproduction by liver; underutilized by body

• Gluconeogenesis (making glucose from glycerol and amino

acids)

• Renal tubular transport of glucose to the urine due to

hyperglycemia

• Incretin system deviations (relationship to DM still not fully clear)

• Glucagon-like peptide 1 (GLP-1)

• Glucose dependent insulinotropic peptide (GIP)

8

Who has Diabetes?

• Incidence of diabetes is rising (about 25 million adults in the

US)

• Incidence is higher in certain populations

• Many risk factors/associated conditions are also rising in

prevalence

• About 2/3 of patients with diabetes in the US also have

hypertension (HTN)

• How does Maine compare to the US when it comes to incidence

of Diabetes?

9

Incidence of Diabetes in the US

Diabetes Report Card 2012. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2012.

Centers For Disease Control and Prevention. Diabetes Data and Trends. .http://apps.nccd.cdc.gov/DDT_STRS2/NationalDiabetesPrevalenceEstimates.aspx?mode=DBT

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Diabetes in the US

• Incidence increases

with age

• Incidence ranges from

7.1% - 16.1% between

different racial/ethnic

groups


11

New Cases of Diabetes


12

Rates of Diabetes in Maine have

been similar to that of the US

Diabetes Surveillance Report, Maine 2012. Augusta, ME: Diabetes Prevention and Control Program, Maine Center for Disease Control and Prevention; 2012.

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Diabetes Incidence in Maine


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Prevalence Varies throughout Maine from 7% to 10.7%


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Diabetes Disease Burden

• 2009 in Maine, diabetes related deaths had incidence of 65.8 per 100,000

• Decreased from 81.5 per 100,000

• US 2008 incidence was 72.2 per 100,000

• Significantly increased risk of cardiovascular diseases

• Including stroke and myocardial infarction (MI)

• Leading cause of

• Non-traumatic lower extremity amputations, blindness, and kidney failure

• Medical expenditures are on average 2.3 times higher in patients with

diabetes than those without (~ $ 174 billion in direct + indirect costs in

2007)



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Microvascular Complications:

• Nephropathy

• Retinopathy

• Neuropathy

• Foot ulcers/lesions

• Numbness, pain

• Sexual dysfunction

• Gastroparesis

http://www.mayomedicallaboratories.com/images/articles/communique/2009/09fig1.jpg

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Macrovascular Complications

• Cardiovascular Diseases (CVD)

• Coronary Artery Disease (CAD)

• Myocardial Infarction (MI)

• Stroke or transient ischemic attack (TIA)

• Peripheral Artery Disease (PAD)

http://womenshealth.gov/heart-health-stroke/images/heart-attack-signs.gif

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Additional Concerns

• Depression and other mental disorders

• Dental disease

• Increased risk of infection

• Can affect fertility

• Severe hyper- or hypo- glycemic events

http://diabeticradio.com/wp-content/uploads/2010/06/hypoglycemia.jpg

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Diabetes Preventative Care


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Preventative Care in Maine


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How do we classify and diagnose diabetes?

• Types

• Diagnosis

• Screening

• Case

http://a.abcnews.com//images/Health/diabetes_Screening3_mn.jpg

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Diabetes Classification

• Type 1 Diabetes

• Type 2 Diabetes

• Gestational Diabetes (GDM)

• Other types related to other causes

• Exocrine diseases (i.e. cystic fibrosis)

• Genetic defects affecting insulin action or production

• Drug/chemically induced (i.e. HIV/AIDs treatments)

American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care. 2013;36(1): S11-S66.

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Diagnosis of Diabetes:Measurements that may be used

• Fasting Plasma Glucose (FPG)

• Blood glucose measured after 8 hours fasting

• Oral Glucose Tolerance test (OGTT)

• Blood glucose measured 2 hours after 75 gram glucose load (use of

anhydrous glucose solution)

• Glycosylated hemoglobin or Hemoglobin A1c (A1C)

• Test without regard to meals, provides 3 month mean glucose

• Random plasma glucose (PG)

• For use in patients with symptoms of hyperglycemia/hyperglycemic crisis


24

Diagnosis of Diabetes: Symptoms/Presentation

• Assessment for signs and symptoms of hyperglycemia

• Excess thirst, urination, and/or hunger

• Blurry vision or vision changes

• In severe hyperglycemia (BG > 240 mg/dL)

• Ketones may be present in urine

• Ketoacidosis can occur when the body breaks down fat and other

molecules for energy

• Can not use glucose for energy without insulin

25

Diagnosis of Diabetes:Values for Diabetes/Pre-Diabetes

MeasurementCriteria for Diabetes

Criteria for Pre-Diabetes

FPG ≥ 126 mg/dL 100 - 125 mg/dL

OGTT ≥ 200 mg/dL 140 - 199 mg/dL

A1C ≥ 6.5% 5.7 - 6.4%

Random PG ≥ 200 mg/dL N/A


26

Pre-Diabetes Diagnosis

• Plasma glucose and/or A1C level between normal range

and diabetes

• Risk for developing DM and CVD

• Estimates for developing diabetes over 5 years

range from 9 - 50 %

• Evaluate and treat other risk factors:

• Obesity/overweight, dyslipidemia, and hypertension


27

Who to Test/Screen for Diabetes?

• For which patients should you be

recommending testing/screening for Diabetes?

• When/How often should they be screened?

• Evaluate individual patient risk

• Assess previous screening results

• What risk factors can you name?

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Risk Factors*Obesity/overweight (BMI ≥ 25 kg/m2) History of CVD

Physical inactivity Prior diagnosis of pre-diabetes

First degree relative with DM HDL cholesterol < 35 mg/dL

High risk ethnicity/race:• African American• Latino• Native American• Asian Amerian• Pacific Islander

Triglycerides > 250 mg/dL

Hypertension: BP ≥ 140/90 mmHgor on treatment

Conditions associated with insulin resistance:

• Severe obesity (BMI ≥ 40 kg/m2)• Acanthosis Nigrans

Women with history of GDM or delivering a baby weighing > 9 lbs

Women with Polycystic Ovarian Syndrome (PCOS)

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Who to Screen for Diabetes?

• All adults ( ≥ 18 years old) with BMI ≥ 25 kg/m2 and 1 or

more additional risk factors*

• In adults without additional risk factors

• Screening should start at age 45

• If results of screening are normal; repeat in 3 years

• Repeat yearly in those with Pre-diabetes values

• For diagnosis screening test must be repeated

• Is better to use same test (i.e. A1C, FPG, etc) for repeat


30

Screening in Children and Adolescents

• Test for type 2 diabetes and pre-diabetes in children/adolescents

• Overweight (BMI > 85th percentile for age and gender or >

120% of ideal weight for height)

• Plus 2 risk factors:

• Family history in 1st or 2nd degree relative

• Race/ethnicity (same as in adults)

• Signs of insulin resistance or associated conditions

• Gestational DM in mother while child was in utero


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Screening for Gestational Diabetes

• Screen at first pre-natal visit for those with risk factors

• Without risk factors screen at 24-28 weeks

• Use OGTT for diagnosis (fasting, 1 hour, and 2 hour)

• FPG ≥ 92 mg/dL

• 1 hour ≥ 180 mg/dL

• 2 hour ≥ 153 mg/dL

• In women with gestational DM, screen for type 2 DM at 6-12

weeks post-delivery then every 3 years


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Who to screen for Diabetes?

• 1. Which of the following symptom-free patients is due to be screened for

diabetes today?

•A. 50 year old Latina female who delivered a baby weighing 10 lbs when

she was 27, but had a negative diabetes screening test 24 months ago

•B. 25 year old Caucasian female with a BMI of 28 kg/m2 who reports low

to no physical activity and is taking medication to treat his hypertension

•C. 40 year old African American male with a BMI of 24 kg/m2 and family

history significant for diabetes in his mother and maternal grandfather

•D. 42 year old Caucasian male with a BMI of 26 kg/m2 who has no

comorbidities and is physically active, but has never been screened

33

Meet Mr. L. Labor

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Patient: L. Labor

• 25 year old Caucasian Male who frequents your community pharmacy

and has just been to his doctor’s office (routine visit)

• Claims he is generally “healthy” (admits his diet could be better)

• BMI = 28 kg/m2 (height: 73 inches; weight: 215 lbs)

• Has a wife and daughter (~ 1 year old)

• Previously had a very physically active job, but now spends most of

his time sitting at a computer both at work and at home

• Carpentry and Coaching little league v.

• Webpage design and Watching games from the stands with snacks

35

Patient: L. Labor

• He mentions his doctor wants him to get lab work done to

check for diabetes

• He does not understand why

• He feels he is young and healthy

• How can you explain to him the importance and potential

benefit to having the tests done?

• Can you explain to him what diabetes is and what it means

for his health?

36

Interpreting test results

• Which of the following values is one of the criteria for

the diagnosis of pre-diabetes?

•A. Glycosylated Hemoglogbin (A1C) = 6.2 %

•B. Fasting Plasma Glucose (FPG) = 90 mg/dL

•C. Plasma Glucose 2 hours after a 75 grams glucose

load = 130 mg/dL

•D. Glycosylated Hemoglogbin (A1C) = 5.7 %

37

Diagnosis of Diabetes:Values for Diabetes/Pre-

DiabetesMeasurement

Criteria for Diabetes

Criteria for Pre-Diabetes

FPG ≥ 126 mg/dL 100 - 125 mg/dL

OGTT ≥ 200 mg/dL 140 - 199 mg/dL

A1C ≥ 6.5% 5.7 - 6.4%

Random PG ≥ 200 mg/dL N/A

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Interpreting test results

• What does it mean if LL’s lab test shows:

•Glycosylated Hemoglogbin (A1C) = 6.0 %

•And

•Fasting Plasma Glucose (FPG) = 110 mg/dL

• What else would you like to know about him or test for?

• What should we recommend for him going forward?

39

Next Steps

•To prevent/delay the onset of Type 2 Diabetes in patients who have

been diagnosed with Pre-diabetes, which of the following are

recommended as part of an ongoing support plan:

•A. Weight loss of 7% of the patient’s initial body weight

•B. Moderate physical activity for a minimum of 150 minutes/week

•C. Initiation of canagliflozin therapy

•D. A and B are correct

•E. A, B, and C are all correct

40

Treatment for Pre-Diabetes

http://www.diabetes-warrior.net/wp-content/uploads/2010/10/pre-diabetes1.jpg

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Lifestyle Modifications for Pre-Diabetes and Diabetes

• Medical Nutrition Therapy (MNT)

• Moderation, variety of carbohydrates

• Increased physical activity

• Minimum 150 minutes/week moderate level

• Weight loss/maintenance

• Initial 7% of body weight and maintenance of weight loss

• Smoking cessation

• Encourage and support with counseling and/or

pharmacotherapy


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• Can decrease progression from pre-DM to DM

• Group and individual delivery methods have both been found to

be effective

• Monitoring for and managing other CVD risk factors:

• Hypertension (HTN)

• Hyperlipidemia (HLD)

• Overweight/obesity (especially excessive abdominal fat)

• Tobacco use


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• What specifically could you recommend

for LL?

• Work with 1 -2 others for 2-3 minutes

writing down specific recommendations

for LL

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Specific Recommendations for LL:

• Smoking cessation (assessment of readiness to quit)

• Healthful diet and exercise plan with goal of 15 lbs weight loss

• Limit intake of high sugar beverages

• Increase intake of whole grains to obtain recommended intake of

fiber

• Recheck BP, recommend treatment if it continues to be elevated

• Check fasting lipid panel, recommend treatment if levels are

elevated

• Annual monitoring for development of DM

• Medication therapy for Pre-Diabetes?


45

Pharmacotherapy for Pre-Diabetes

•Which of the following answers lists medications that can help

prevent/delay the progress from pre-diabetes to diabetes?

•A. Pioglitazone and Glipizide

•B. Orlistat and Sitagliptin

•C. Acarbose and Pioglitazone

•D. Any of the above

46

Metformin for Pre-Diabetes

• Can be considered for all patients with Pre-diabetes as

adjunct to lifestyle modification

• Especially recommend for patients with

• Elevated FPG ( > 100 mg/dL)

• BMI > 35 kg/m2

• Aged < 60 years old

• History of GDM (women)


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Progress….

• LL follows recommendations from you and his other health

care providers

• He is able to quit smoking with nicotine patches and

counseling, but during this time his weight goes up 2.5 kg

• About 6 months later he begins a diet and exercise

program for patients with Pre-Diabetes

• He is able to loose ~ 20 lbs but has been struggling to

keep from gaining it back

48

Progress….

• LL has tolerated Metformin therapy and is now

taking 1 gram BID

• He is exercising more, but he is still having

difficulties balancing his diet

• He was diagnosed with high blood pressure

• Not currently on therapy - improved with

smoking cessation and weight loss

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8 years later….

• He comes into the pharmacy today for his Metformin

refill and reports bad news…

• Despite his lifestyle changes he has been diagnosed

with type 2 diabetes

• His A1c has reached 8.1% and he has had two FPGs >

140 mg/dL drawn by the lab over 2 weeks

• He is motivated to continue with his lifestyle changes,

but wants to know more about additional medications

50

Adding on more medications

• Individually take 1 minute to list additional diabetes

therapies that could be added to LL’s Metformin for

better glycemic control

• In pairs take a few minutes to discuss your options

• Select and write down one agent/class that you

would recommend for him based on his current

status

• Write down why you think it is a good choice for him

51

Adding on Therapy

• While metformin is still the preferred first line therapy for patients with diabetes, if

maximum doses of metformin do result in an A1C at goal, how should an additional

agent be chosen?

•A. The second agent added on should be a Glucagon-Like-Peptide-1 (GLP-1)

receptor agonist

•B. The second agent added on should be selected based on patient specific factors

with consideration of cost, potential side-effects, and comorbidities

•C. The second agent should be insulin therapy with insulin glargine daily and

insulin aspart or lispro TID with meals

•D. A second agent should not be added until diet and lifestyle goals have been

achieved to reduce insulin resistance

52

A Patient Centered Approach

• American Diabetes Association (ADA) and the European

Association for the Study of Diabetes (EASD) 2012

recommendations

• Patient be involvement in decision making

• Patient factors be considered in selecting treatments

and goals of therapy

• Most add-on therapy will offer similar glycemic benefit,

but compliance and risk of adverse events varies

Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:1364-79.

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Factors to Consider

• Think of each element as a continuous spectrum:

• Patient attitude and expected treatment efforts

• Risks of hypoglycemia and other adverse events

• Disease duration

• Life expectancy

• Important comorbidities

• Established vascular complications

• Resources, support system available


54Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:1364-79.

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Factors to Consider

• Factors should also be considered in prescribing lifestyle

modifications

• Setting goals that are realistic

• Adapting to patient situations

• These may include:

• Access to healthful foods

• Access to a safe environment for exercise

• Patient’s physical ability (i.e. Fall risk, respiratory conditions)

56

Adding on Therapy

• While metformin is still the preferred first line therapy for patients with

diabetes, if maximum doses of metformin do result in an A1C at goal, how

should an additional agent be chosen?

•B. The second agent should be insulin therapy with insulin glargine daily

and insulin aspart or lispro TID with meals

• This strategy of starting insulin as first line (with or without metformin) may

be appropriate for patients with severe hyperglycemia at time of diagnosis or

therapy initiation

•A1C ≥ 10% or Blood glucose > 300 mg/dL


57

Adding on Therapy

• While metformin is still the preferred first line therapy for

patients with diabetes, if maximum doses of metformin do

result in an A1C at goal, how should an additional agent be

chosen?

•A. The second agent added on should be a Glucagon-Like-

Peptide-1 (GLP-1) receptor agonist

• This may be appropriate for patients in whom weight gain is

desirable, patient has insurance that will cover cost (reasonable

copay), and patient feels comfortable with injectable therapy


58

Oral Medication Options

59

New Oral Options

• Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors

• Dapagliflozin (Forxgia)

• 2011, FDA declined approval (concerns over risk of breast

and bladder cancer)

• July 2012 NDA resubmitted to FDA with new data

• Has been approved in the EU, Australia, New Zealand,

Mexico, and Brazil

• Canagliflozin (Invokana) - approved earlier this year

60

New Oral Options

• Sodium-Glucose cotransporter 2 (SGLT2) inhibitors

• Lowers blood glucose by decreasing the amount of

glucose re-absorbed by the kidneys

• Canagliflozin (Invokana®)

• Moderate A1C reduction and weight reduction

• Low incidence of hypoglycemia

• Renal monitoring and dose adjustment

Invokana (package insert). Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2013; http://www.invokanahcp.com/. Accessed: 08/28/13.

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Canagliflozin (Invokana®)

• Approved for treatment of adults with type 2 Diabetes in conjunction with

lifestyle interventions

• Initiate at 100 mg PO daily, before first meal of the day

• Can increase to 300 mg PO daily if eGFR ≥ 60 mL/min (if less max dose =

100 mg/day)

• Contraindicated with hypersensitivity, ESRD, dialysis

• Avoid or discontinue if eGFR < 45 mL/min

• Additional Warnings include:

• Hypotension, hyperkalemia, hypoglycemia, mycotic genital infections,

and increased LDL cholesterol


62

Canagliflozin (Invokana®)


63

Injectable Medication Options

• Insulins

• Long acting, short acting, rapid acting, and premixes

• Insulin Degludec - FDA declined approval; requesting more data

• Glucagon-like peptide - 1 receptor agonists

• Exenatide, liraglutide

• Albiglutide - may be next agent in class (FDA petition submitted by

GlaxoSmithKline Jan 2013); proposed for once weekly injection

• Amylin mimetics

• Pramlintide - use with insulin; mostly in patients with type 1 DM

64

Ultra-long Acting Insulin?

• Insulin Degludec

• Proposed to have > 24 hour activity to give better once

daily dose coverage than other products

• Half-life ~ 42 hours

• FDA declined to approve as of Feb 2013

• Requested more long term cardiovascular safety data from

dedicated trial

• Has been approved in the European Union

Tucker ME. FDA rejects Novo Nordisk’s Insulin Degludec. Medscape News. Available at: http://www.medscape.com/viewarticle/779077

65

Injectable Agent Dosing

• Which of the following answers correctly lists medication name,

strength, and starting dose for a Glucagon-Like Peptide-1 (GLP-1)

receptor agonist?

•A. Liraglutide (Victoza®) 0.6 mg injected SubQ once daily without

regard to meals

•B. Exenatide (Byetta®) 5 mg injected SubQ BID 60 minutes or less

before a meal

•C. Exenatide (Bydureon®) 2 mg injected SubQ once weekly, must be

with a meal

•D. Both A and C are correct


66

Back to adding on therapy

• Any changes in what you would like to recommend for LL?

• Comparative analysis of add-on therapy has indicated

that most 2 drug combinations have similar A1C lowering

effects

• Variance is greater in incidence of hypoglycemia and

other side-effects

• For each patient must consider risk v. benefit of each

medications positive and negative effects

Bennett WL, Maruthur NM, Singh S, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med. 2011;154:602-13.

67Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach, Position Statement by the ADA and the EASD. Diabetes Care. 2012;35:1364-79.

68

Goals for therapy

• Choosing an A1C goal for a patient should be individualized just like

the therapy selected

• Guidelines recommend lowering A1C to below or around 7% to

reduce microvascular complications (range 6.5% - 8%)

• May also reduce macrovascular complications in some patients if

implemented soon after diagnosis

• For other patients, older, greater duration of disease, benefit of

lower A1C may not outweigh risk of hypoglycemia

• Variance in cardiovascular outcomes between large trials


69

Brief on Trials for Tight Glycemic Control

• UKPDS

• Intensive Control associated with improved microvascular outcomes

• ACCORD

• Intensive therapy/targets increased mortality without significantly reducing

cardiovascular events

• ADVANCE

• Intensive control resulted in relative reduction of combined major cardiovascular

events and microvascular events

• VADT

• No significant effect on rates of major cardiovascular events, death, or

microvascular complications

Stratton IM, Adler AI, Neil HAW, et al. BMJ. 2000;321:405-12. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Group. NEJM. 2008;358(24):2545-59.

The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) Collaborative Group. NEJM. 2008;358(24):2560-72. Duckworth W, Abraira C, Moritz T, et al. NEJM. 2009;360(2):129-39.

70

Meta-analysis on tight glycemic control

• Lancet 2009: based on 5 randomised trials

• Intensive therapy reduces coronary events without an increased

risk of death

• Notes variance between populations and rate of A1C reduction

• BMJ 2011: based on 14 randomised trials (used trial sequence analysis)

• Intensive control has not been proven to reduce all cause mortality

• Increase in relative risk of hypoglycemia by 30 %

• Evidence insufficient to draw conclusions on cardiovascular

mortality, non-fatal MI, composite microvascular complications, or

retinopathy

Ray KK, Kondapally Seshasai S, Wijesuriya S, et al. Lancet. 2009;373:1765-72.Hemmingsen B, Lund SS, Gluud C, et al. BMJ. 2011;343:d6898 Doi: 10.1136/bmj.d6898.

71

Meta-analysis on tight glycemic control

• BMJ 2011: based on 13 studies

• Limited benefits to all cause mortality and cardiovascular-related

death

• Values on both sides of the debate can not be ruled out by this

analysis

• Risk and benefit for microvascular and macrovascular

complications - inconclusive

• Risk of harm with hypoglycemia noted

• Need for more trials

Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, et al. BMJ. 2011;343:d4169 doi:10.1136/bmj.d4169.

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What should be goal for LL?

• What do you think we should set at LL’s A1C goal?

• How about other goals/plans?

• Self-monitoring of blood glucose (SMBG)

• Preventative Care

• Cardiovascular risk reduction

• Medical Nutrition Therapy (MNT)

73

Potential Plans for LL

• A1C ≤ 7% (depending on response to therapy)

• Check A1C at least twice per year

• Check more often when changing therapies or above goal

• Diabetes Self-Management Education (DSME) and support

• Initial education plus follow-up

• Education should address quality of life and psychosocial

issues

• May be recommended for patients with Pre-Diabetes as well


74

Potential Plans for LL

• SMBG

• Part of comprehensive DM education and care discussion with

patient

• Daily monitoring is not required for most patients not taking insulin

• Consider patient comfort, access to testing supplies, and risk of

hypoglycemia based on medication therapy

• Goals and frequency should be individualized; can consider:

• Fasting BG range 70 - 130 mg/dL

• Peak Post-prandial BG < 180 mg/dL (taken 1-2 hours after meal)


75

Medical Nutrition Therapy

• Weight loss (overweight/obese) and weight maintenance

• Use of low carbohydrate, low fat calorie-restricted, or Mediterranean diet

• Monitor lipids, renal function, and protein intake

• Individual diet plan for intake of carbohydrates, proteins, and fats

• Saturated fat < 7 % of total calories (9 calories per gram of fat); limit trans

fats

• Addition of physical activity (design to meet patient’s ability)

• Increase intake of whole grains to get recommended daily intake for fiber

• Limit alcohol intake to moderate (1 drink per day women; 2 per day men)

• Specific vitamin supplementation not currently supported by evidence


76

Cardiovascular Prevention

• Hypertension

• New goal option of systolic < 140 mmHg; Diastolic < 80 mmHg

• Lower targets (< 130 mmHg) may be appropriate for specific

patients (younger)

• Preferred treatment

• DASH Diet and lifestyle modification

• Angiotensin Converting Enzyme (ACE) Inhibitors or Angiotensin

Receptor Blocker (ARB) (monitor renal function and electrolytes)

• Addition of diurectics or other agents may be required to reach goal


77


• Hyperlipidemia

• Monitor fasting lipids annually

• Or every 2 years if at goal and stable

• Lifestyle modifications recommended for all patients

• Recommend addition of HMG-CoA Reductase Inhibitor (statin)

therapy regardless of baseline lipid values if patient has CVD

or

• Over the age of 40 with 1 or more CVD risk factors

• Family history of CVD, HTN, smoking, albuminuria,

dyslipidemia

78


• Hyperlipidemia

• For lower risk individuals add statin if

• Lifestyle changes alone do not reduce LDL to < 100 mg/dL

• Patient has multiple CVD risk factors

• If patients do not meet goals (see next slide) on maximum

tolerated statin dosing

• Alternative goal: LDL reduction by 30 - 40 % from baseline

• Combination therapy has not been shown to have additional

cardiovascular benefit


79


• Hyperlipidemia

• LDL Goals (primary target of therapy)

• < 100 mg/dL for patients without CVD

• < 70 mg/dL for patients with CVD

• Triglyceride goal < 150 mg/dL

• HDL goal for men > 40 mg/dL

• HDL goal for women > 50 mg/dL


80


• Anti-platelet agents

• Can use aspirin 81 mg daily as primary prevention in patients

with type 1 or type 2 DM at increased risk( 10 year risk > 10%)

• Includes most men > 50, women > 60 with at least 1 risk

factor

• For patients with lower risk (10 risk < 5%) with no risk factors -

therapy is not recommended

• For patients at moderate risk, must weigh risks and benefits

• For secondary prevention, aspirin 81 mg is recommended

• May use clopidogrel with documented aspirin allergy


81

General Prevention

• Monitoring of renal function

• Treatment of elevated urinary albumin excretion with ACE

Inhibitors or ARBs

• Eye exams yearly

• Foot care and exams

• Skin care

• Vaccinations

• Social support


82

Prevention: Immunizations

• You are working with a 30 year old gentleman who has just

been diagnosed with type 2 Diabetes. Which vaccines would

you recommend he receive if he has not done had them

already?

•A. Hepatitis B series

•B. Influenza (to be repeated annually)

•C. Pneumoccal Polysaccharide

•D. Both B and C are correct


83

Useful Abbreviations:ADA American Diabetes Association

A1c or A1c Hemoglobin A1c

FPG Fasting Plasma Glucose

OGTT Oral Glucose Tolerance Test

BG Blood Glucose

IFG Impaired Fasting Glucose

IGT Impaired Glucose Tolerance

DM Diabetes Mellitus

HTN Hypertension

HLD Hyperlipidemia

MI Myocardial Infarction

CAD Coronary Artery Disease

CVD Cardiovascular Disease

PAD Peripheral Artery Disease

TIA Transient Ischemic Attack

84

References: • American Diabetes Association (ADA) Professional Practice Committee. Standards of medical care in diabetes - 2013. Diabetes Care.

2013;36(1): S11-S66.

• Centers for Disease Control and Prevention. Diabetes Report Card 2012. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2012. Available at: www.cdc.gov/diabetes/pubs/pdf/DiabetesReportCard.pdf

• Centers for Disease Control and Prevention. National Diabetes Fact Sheet, 2011. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2011. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.

• Diabetes Surveillance Report, Maine 2012. Augusta, ME: Diabetes Prevention and Control Program, Maine Center for Disease Control and Prevention; 2012. Available at: http://www.maine.gov/dhhs/mecdc/population‐health/dcp/statistics.htm

• Maine Center for Disease Control and Prevention. Maine Diabetes Prevention and Control Program, Health Fact Sheet: Diabetes in Maine. Maine Center for Disease Control and Prevention, Maine Department of Health and Human Services; 2011.

• Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach, Position Statement by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364-79.

• Invokana (package insert). Janssen Pharmaceuticals, Inc. Titusville, NJ. March 2013; http://www.invokanahcp.com/. Accessed: 08/28/13.

• Stratton IM, Adler AI, Neil HAW, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405-12.

• The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Group. Effects of intensive glucose lowering in type 2 diabetes. NEJM. 2008;358(24):2545-59.

• The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. NEJM. 2008;358(24):2560-72.

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References (continued)• Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in veterans with type 2 diabetes. NEJM. 2009;360(2):129-39.

• Ray KK, Kondapally Seshasai S, Wijesuriya S, et al. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Lancet. 2009;373:1765-72.

• Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, et al. Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: a meta-analysis of randomised control trials. BMJ. 2011;343:d4169 doi:10.1136/bmj.d4169.

• Hemmingsen B, Lund SS, Gluud C, et al. Intensive glycaemic control for patients with type 2 diabetes: systemic review with meta analysis and trial sequence analysis of randomised clinical trials. BMJ. 2011;343:d6898 Doi: 10.1136/bmj.d6898.

• Ismail-Beigi F, Moghissi E, Tiktin M, et al. Individualizing glycemic targets in type 2 diabetes mellitis: implications of recent clinical trials. Ann Intern Med. 2011;154:554-9.

• Bennett WL, Maruthur NM, Singh S, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med. 2011;154:602-13.

• Matthews JE, Stewart MW, De Boever EH, et al. Pharmacodynamics, pharmacokinetics, safety, and tolerability of albiglutide, a long-acting glucagon-like peptide-1 mimetic, in patients with type 2 diabetes. J Clin Endocrinol Metab. 2008;93:4810-4817.

• Garber AJ, King AB, Del Prato SD, et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomized, open-label, treat-to-target non-inferiority trial. Lancet. 2012;379:1498-507.

• Nisly SA, Kolanczyk DM, and Walton AM. Canagliflozin, a new sodium – glucose cotransporter 2 inhibitor, in the treatment of diabetes. Am J Health-Syst Pharm. 2013;70:311-9.

• Tucker ME. FDA rejects Novo Nordisk’s Insulin Degludec. Medscape News. Accessed February 12, 2013. Available at: http://www.medscape.com/viewarticle/779077

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